Software / Hardware

GAMP5 (Guide for Validation of Automated Systems)

The automation compliance to GAMP5 is autocertify from Comecer following a development sequence of the project called “Life cycle“; This autocertify is done by preparing the following documents, that describe the functional charateristic of the Hardware and the test for its validation:

FDS (Functional Design Specification)

HDS (Hardware Design Specification)

STS (Software Test Specifications)

HTS (Hardware Test Specifications)

Change Control

CFR21 part11 (Electronic records, electronic signatures)

The compliance of software to the regulation CFR21 part11 is autocertify from Comecer following a documented analysis of the regulation requirements; Comecer describes how this requirements are applied in software development. Also the requirements of CFR21 part11 are validated with a test protocol (STS Software Test Specifications).